Kornimate/medical-research-clean huggingface dataset:
randomised exposure study of pollution indoors and respiratory effects

Conditions: Respiratory Tract Infections; Pneumonia

Summary: the purpose of this study was to determine whether reduced exposure to indoor air pollution would reduce alri incidence in children \<18 months of age. households were randomized to receive a chimney stove (intervention group) or continue using an open fire for cooking and heating (control group).

acute lower respiratory infections (alri) are the chief killer of children. most cases are pneumonia and the majority occur among poor children under five years in developing countries. poverty might be said to be the primary cause, which manifests as malnutrition, including micro-nutrient deficiencies, and lack of access to medical care. another attribute of poverty is household indoor air pollution (hap) from use of unprocessed solid fuels such as biomass (wood, animal dung and crop wastes) and coal in simple stoves. a meta-analysis of published observational studies found that young children exposed to smoke from household solid fuel use had a rate of alri twice that of children not exposed or where clean fuels were used. recent studies have shown similar alri risks associated with short-term air pollution measurements and other indicators of exposure.

Eligibility criteria:
inclusion criteria: households were invited to participate in the study if they met the following inclusion criteria: * used only an open fire for cooking and heating * had a pregnant woman or child \< 4 months residing in the home * identified as mam (the regional ethnic group), and had * minimal summer migration (less than 12 weeks per year) exclusion criteria: households were excluded from participating if: * the household was already using a chimney stove for cooking * there was no child \<4 months of age or a pregnant woman residing in the home * seasonal migration required the family to move to another region for more than 12 weeks of the year
octreotide compared to placebo in patients with inoperable bowel obstruction due to peritoneal carcinomatosis

Conditions: Peritoneal Neoplasms; Intestinal Obstruction; Carcinomatosis

Summary: to evaluate in combination with corticosteroid and local standard medical care the efficacy and safety of long-acting octreotide compared to placebo for the treatment of symptoms of inoperable bowel obstruction in patients with peritoneal carcinomatosis


Eligibility criteria:
inclusion criteria: * patients with symptoms and signs of inoperable bowel obstruction confirmed by a surgeon or clinic and radiographic assessment (ct scan or at least abdominal x-ray); * confirmed peritoneal carcinomatosis (with one of the following criteria : surgery, imaging and/or cytology); * no corticotherapy at dose more than 1mg/kg equivalent-methylprednisolone, in the previous 2 weeks ; * no chemotherapy in the previous week; * no radio or chemotherapy planned at the inclusion and within the two weeks following inclusion * authorized concomitant treatments for local standard medical care : antiemetics, antispasmodics, anti-histamine2 (h2) drugs blockers or proton pump inhibitor, analgesics; nasogastric tube exclusion criteria: * abnormal coagulation (prothrombin time \< 60%, platelets \< 50x10\^9/l). * non authorized concomitant treatments : 1. anticholinergics such as scopolamine 2. other somatostatin analogues other protocol-defined inclusion/exclusion criteria may apply

Keywords: bowel obstruction, peritoneal carcinomatosis octreotide inoperable
primovist / eovist in renally impaired patients

Conditions: Contrast Media

Summary: patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (mri) scan and injection with a contrast agent, primovist/eovist, will be asked to participate. the administration of contrast agents that contain gadolinium such as primovist/eovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (nsf) in patients with renal impairment. this study is to assess the potential risk to develop nsf in patients with renal impairment after the administration of primovist/eovist. patients who are enrolled in this study will receive a primovist/eovist enhanced mri scan which was prescribed by the referring doctor. after the mri scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of nsf have appeared.

adverse events data will be reported in adverse events section.

Eligibility criteria:
inclusion criteria: * patient must be scheduled for contrast enhanced magnetic resonance imaging (ce-mri) of the liver with primovist/eovist based on careful risk/benefit evaluation at the recommended dose in one of the approved indications * patient must fulfill criteria for moderate (estimated glomerular filtration rate \[egfr\] 30 - 59 ml/min/1.73 m\^2) to severe (egfr \< 30 ml/min/1.73 m\^2) renal impairment. exclusion criteria: * gadolinium based contrast agent (gbca)-enhanced mri (or administration of a gbca for any other ce imaging procedure) other than primovist/eovist within 12 months prior to administration of primovist/eovist * history of existing nsf

Keywords: nephrogenic systemic fibrosis (nsf) primovist / eovist
hypercortisolism and epicardial adipose tissue

Conditions: Hypercortisolism

Summary: identifying hypercortisolism patients at risk for cardio-vascular events despite biological cure, and determine which patients should be particularly followed. hypercortisolic patients represent an ideal in vivo model to determine the interactions between glucocorticoids and ectopic fat development.


Eligibility criteria:
inclusion criteria: * major, male or female * introducing an active or healed hypercortisolism caused by cushing's disease * signed informed consent. exclusion criteria: * elderly patients under 18 years * pregnant or lactating women * previous history of myocardial infarction * antecedent congenital cardiomyopathy * adrenocorticotropic hormone-independent hyperadrenocorticism * hyperadrenocorticism by ectopic adrenocorticotropic hormone secretion * treatment with corticosteroids or insulin * specific contraindication to the achievement of nuclear magnetic resonance (metal heart valves, pacemakers, metallic foreign body, claustrophobia) * persons deprived of liberty * persons not affiliated to a social security scheme * people unable to give their consent in writing (in person or with the assistance of a third party).
unified cognitive-behavioral therapy (cbt) vs. combined cbt and dance/movement therapy (dmt) for anxiety disorders

Conditions: Anxiety Disorders

Summary: the current pilot study will examine and compare the effectiveness of two group psychotherapies for mixed anxiety disorders: 1. unified cognitive-behavioral protocol, adapted to a group format. 2. combined cognitive-behavioral and dance/movement therapy. in addition, change in proposed mechanism in each therapy will be examined, along with their association with change in outcome measures during therapy.

the current pilot study will examine and compare the effectiveness of two group psychotherapies for mixed anxiety disorders: 1. unified cognitive-behavioral protocol, adapted to a group format. 2. combined cognitive-behavioral and dance/movement therapy. 24 patients will be randomized to 1 of the two treatment arms and treated with 20 weekly 1.5-2 hours therapy sessions. independent evaluator and self-reports measures will be collected at intake, pre-treatment, session by session, post-treatment and and follow-up. hypotheses: 1. both groups will show effectiveness, as revealed by reduction in anxiety severity and increase in valued living. 2. changes in process measures (proposed mechanism of change - emotion regulation, working alliance, fear of bodily sensations, bodily/movement awareness) will be predictive of change in outcome measures (anxiety severity and valued living). 3. changes in bodily/movement awareness will be more predictive of change in outcome measures in the cbt-dmt group than in the unified protocol group.

Eligibility criteria:
inclusion criteria: * one of the following primary axis i dsm-iv-tr diagnoses: panic disorder with or without agoraphobia; social anxiety disorder; generalized anxiety disorder; anxiety disorder not otherwise specified; adjustment disorder with anxiety; adjustment disorder with mixed anxiety and depressed mood * if on medication or in other types of treatments, patients must be willing to remain stable on their treatment for the duration of the acute phase of the study (5-6 months) * provision of written informed consent exclusion criteria: * current or past schizophrenia, psychosis, or bipolar disorder. * current suicidal ideation. * current substance/alcohol dependence or abuse. * cluster a or b personality disorder. * pregnancy (for women).

Keywords: anxiety disorders group psychotherapy cognitive-behavioral therapy dance/movement therapy cbt dmt unified protocol
automatic remifentanil administration guided by ani during propofol anesthesia

Conditions: Nociceptive Pain; Surgical Procedure, Unspecified

Summary: prospective randomized monocentric clinical trial during propofol anesthesia. the aim of the study is to test whether the use of a medical device designed to automatically administer remifentanil during surgery based on expert rules and continuous reading of heart rate, blood pressure and the analgesia nociception index results in lower overall remifentanil administration versus standard practice.

prospective randomized monocentric clinical trial during propofol anesthesia. * inclusion: asa 1, 2 or 3 adult patients scheduled to undergo burn wound surgery in a burn center (university hospital of lille, france) * arm 1 : remifentanil will be automatically administered by an expert system guided by heart rate, blood pressure and the analgesia nociception index (ani). * arm 2 : remifentanil will be administered by a target controlled device using the minto pk/pd model. * propofol is administered throughout the procedure with a target controlled device using the pk/pd model of schnider. the target will be guided by the bispectral index values. * primary endpoint : overall normalized remifentanil administration. * secondary endpoints : relative amount of time spent in a state of hemodynamic reactivity ; relative amount of time the ani spends in the \[0-50\], \[50-70\] and \[70-100\] windows ; relative amount of time the bis spends in the \[0-40\], \[40-60\] and \[60-100\] ; hemodynamic status at various times during anesthesia ; total amount of target modifications of remifentanil and propofol ; total amount of morphine administered in pacu ; total amount of ketamine administered in pacu ; incidence of nausea/vomiting in pacu ;

Eligibility criteria:
inclusion criteria: * asa 1, 2 or 3 adult patients scheduled to undergo burn wound surgery at the burn center of the university hospital of lille exclusion criteria: * bmi outside \[17 - 35 kg/m2\] * pregnancy or breast feeding women * non sinus cardiac rhythm * documented dysautonomia * complicated diabetes mellitus * known allergy to a drug used in the clinical trial

Keywords: general anesthesia analgesia/nociception balance monitoring expert system
incidence of opioid-induced respiratory depression in medical and trauma patients

Conditions: Respiratory Depression; Sedation

Summary: the primary objective of this prospective, blinded observational study is to correlate assessment of sedation and respiratory status with capnography and pulse oximetry monitoring in hospitalized adult medical and trauma patients receiving patient-controlled analgesia (pca) or nurse administered intravenous (iv) opioids for acute pain. nursing assessment of respiratory status and sedation level will be correlated with capnography and pulse oximetry values as technology-supported monitoring to identify respiratory depression and opioid-induced sedation. the secondary objective is to identify capnography and pulse oximetry values that correlate with respiratory decompensation and opioid-induced sedation in medical and trauma patients on the general care floor.


Eligibility criteria:
inclusion criteria: 1. spontaneously breathing adults 18 to 89 years of age 2. english speaking 3. receiving pca or nurse administered iv opioids for medical or trauma-related pain 4. admitted to the general care floor from the emergency department exclusion criteria: 1. less than 18 or greater than 89 years of age 2. transfer to the general care floor from the intensive care unit 3. receiving intrathecal or epidural opioids 4. inability or unwillingness to wear the etco2 sampling line nasal cannula or pulse oximetry sensor 5. history or diagnosis of a sleep disordered breathing syndrome 6. use of continuous positive airway pressure or (cpap) or bilevel positive airway pressure (bipap) non-invasive ventilation as home regime 7. receiving non-invasive ventilation 8. presence of a co-morbidity that impacts respiration or ventilation (e.g chronic obstructive pulmonary disease or pulmonary fibrosis) 9. unwilling or unable to participate 10. member of a vulnerable population such as pregnant women or prisoners.

Keywords: respiratory depression, opioid-induced sedation
safety and efficacy of recombinant human acid alpha-glucosidase in the treatment of classical infantile pompe disease

Conditions: Pompe Disease; Glycogen Storage Disease Type II; Acid Maltase Deficiency Disease; Glycogenosis 2

Summary: pompe disease is caused by a deficiency of a critical enzyme in the body called acid alpha glucosidase (gaa). normally, gaa is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. in infants with severe cases of pompe disease (called classical infantile pompe disease), an excessive amount of glycogen accumulates and is stored in various tissues, especially heart, skeletal muscle, and liver, which prevents their normal function. this study being conducted to evaluate the safety and effectiveness of recombinant human acid alpha-glucosidase (rhgaa) as a potential enzyme replacement therapy for pompe disease. patients diagnosed with classical infantile pompe disease who have a small, but inactive, amount of natural gaa enzyme present in their bodies (called cross-reacting immunologic material-positive or "crim (+)" patients), will be studied.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of classical infantile pompe disease * endogenous gaa activity \< 1.0% * cardiomegaly * cardiomyopathy * crim (+) * ability to comply with the clinical protocol which will require extensive clinical evaluations exclusion criteria: * respiratory insufficiency * cardiac failure * major congenital abnormality * any other medical condition that could potentially decrease survival * crim (-)
genetic assessment of the patients with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: metabolic syndrome is a combination of medical disorders that increase the risk of developing cardiovascular disease and diabetes. the exact mechanisms of the complex pathways of metabolic syndrome are not yet completely known. the pathophysiology is extremely complex and has been only partially elucidated. most patients are older, obese, sedentary, and have a degree of insulin resistance. stress can also be a contributing factor. the most important factors are: weight, genetics, aging, sedentary lifestyle,excess caloric intake. in our study we will assess the role of some polymorphisms in the pathology of metabolic syndrome.

eligibility criteria to the study: * patients with metabolic syndrome * with written consent

Eligibility criteria:
inclusion criteria: * patients with metabolic syndrome according to idf,aha and nhlbi 2009 exclusion criteria: * diabetes type 1 * cancer * not consent * steroid therapy * alcohol or drug abuse * chronic inflammatory disease * pregnancy or lactation * severe hypothyroidism * immunosuppressive treatment * operation or severe injury during the last month

Keywords: diabetes obesity hypertension dyslipidemia
safety and outcomes associated with continuous versus intermittent infusion vancomycin

Conditions: Infection

Summary: evaluate the safety and outcomes associated between the two treatment modalities

assess the risk of vancomycin-associated nephrotoxicity and outcomes associated with continuous infusions (ci) versus ii dosing in the outpatient parenteral antibiotic therapy (opat) setting

Eligibility criteria:
inclusion criteria: * adult patients at least 18 years of age * receiving wake forest baptist health outpatient parenteral antimicrobial therapy (opat) services * will receive vancomycin therapy from wake forest baptist health specialty home infusion pharmacy * planned therapy with vancomycin in the outpatient setting for at least 2 weeks in duration * prescribed vancomycin with a frequency of either every 12 hours or every 8 hours dosing at the time of enrollment exclusion criteria: * presence of diseases or conditions known to affect the pharmacokinetics of vancomycin: pregnancy/ascites/burn injury/cystic fibrosis /weight greater-than or equal-to 150 kg * pre-existing leukopenia: white blood cell (wbc) \< 4,000 x 103 cells/µl

Keywords: infusion therapy continuous infusions nephrotoxicity outpatient parenteral antibiotic therapy vancomycin
efficacy study of an educational program for decision support for breast cancer

Conditions: Breast Neoplasms

Summary: the purpose of this study is to develop and test an informative computer-based program to help women in making good choices among options for treating early stage breast cancer. women who are exposed to the computerized program will, when compared to women who receive standard of care offered at the hospital: (a) be more knowledgeable about treatment options,(b) be more satisfied with their treatment decision, and (c) be more assured about their treatment choice.

the purpose of this project is to develop and test a computer-based decision support system on breast cancer for low-income women who speak english or spanish. this project is designed to respond to the under utilization of breast conserving surgery by women with early stage breast cancer, as indicated by both national and local data on treatment choices. the literature suggests that underuse of bcs by women for whom it is the recommended therapy may relate to inadequacies in efforts to educate them about treatment options. the program was designed to convey information to women with varying levels of reading ability. this was done through multimedia approaches which include voice-over narrative in simple english or spanish, and use of photo novella and/or "soap opera" presentation of situational material that allows women to explore possible consequences associated with different decisions. comparison(s): women exposed to the computer-based decision support program on breast cancer treatment, receiving standard care and education offered at two public hospitals, compared to women exposed to standard care and education at the same public hospitals.

Eligibility criteria:
inclusion criteria: * female * breast cancer diagnosis in stages i, iia, iib, or iiia * candidates for surgery * speak english or spanish exclusion criteria: * breast cancer diagnosis in stages 0, iiib, or iv * recurrent breast cancer or inflammatory breast carcinoma * not eligible for lumpectomy with radiation

Keywords: decision making patient education indigency minority group
endoscopic ultrasound (eus) guided treatment with humira for crohn's perianal fistulas

Conditions: Crohn Disease; Rectal Fistula

Summary: this study is to assess whether utilizing endoscopic ultrasound(eus) to guide treatment can improve durable fistula healing in patients with crohn's perianal fistulas and to get preliminary information regarding the effectiveness of adalimumab for crohn's perianal fistulas.

prospective randomized trial to assess the effectiveness of rectal eus to guide perianal fistula treatment. our hypothesis is that using imaging, in this case endoscopic ultrasound (eus), to initially evaluate and then guide therapy with an anti-tnf agent (adalimumab) for fistulizing disease will lead to better short- and long-term outcomes.

Eligibility criteria:
inclusion criteria: a patient may be considered for study participation if all of the following apply: * male and female aged 18 years or older; and * a confirmed diagnosis of crohn's disease and one or more identifiable perianal fistulas. exclusion criteria: a patient will be excluded from the study if one or more of the following apply: * females who are pregnant or breast feeding; * infliximab received within 6 weeks prior to study entry; * patients who cannot take, or refuse to take concomitant immunosuppressive therapy with either azathioprine, 6-mercaptopurine, or methotrexate; unless patient has been intolerant of these therapies in the past or is contraindicated as determined by the investigator; * patients who cannot take, or refuse to take concomitant antibiotic therapy; * patients with severe anal stenosis or tenderness which would preclude colonoscopy and / or rectal eus; * patients who cannot take or refuse to take adalimumab; * patients with active or latent tuberculosis; * patients who have had systemic antibiotic, antiviral or antifungal treatment(s) within 3 weeks prior to screening for all non-crohn's related infections; * patients concurrently taking anakinra (kineret); * patients with a history of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma in-situ of the cervix; * patients with chronic hematologic problems such as bleeding dyscrasias; * patients with a history of demyelinating disease (i.e. multiple sclerosis); and * patients with congestive heart failure.
ultrasound index fat fraction

Conditions: Steatosis of Liver

Summary: the objective is to compare the ultrasound index fat fraction (fat plus), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (mri-pdff) in patients to quantify the hepatic steatosis.


Eligibility criteria:
inclusion criteria: * subject is ≥ 18 years old. * subject is able to understand and sign the informed consent form. * subject is able to stand and walk independently. * subject must have at least one or more routine ultrasound imaging procedures of the abdomen, at one of the participating study sites. * subject must have at least one routine liver mri with pdff score performed within 30 days before or after the ultrasound examination * subject is affiliated to national social insurance or a health insurance regimen exclusion criteria: * subject is unable or unwilling to adhere to study procedures * subject is unable to understand the informed consent * subject is unable to express its consent * subject is under legal protection * subject is deprived of liberty by judicial or administrative decision * subject undergoes psychiatric treatment under constraint * subject is pregnant or breastfeeding * subject has latex allergy * subject has an open wound, cut, and/or a rash which would preclude an ultrasound imaging procedure